4 results
Primary Objective * To evaluate the effect of a 6-week treatment with elafibranor versus placebo on hepatic lipid composition in subjects with a fatty liver.Secondary objectives * To evaluate the between treatment difference (elafibranor 120 mg/d vs…
Primary objectives * surrogate endpoint (at interim analysis)To evaluate the efficacy of elafibranor QD for 72 weeks versus placebo on resolution of NASH without worsening of fibrosis.* Resolution of NASH is defined as the disappearance of…
The primary objective of the TactiFlex PAF IDE clinical trial is to demonstrate that ablation with the TactiFlex* Ablation Catheter, Sensor-Enabled* (TactiFlex SE), in conjunction with a compatible RF generator and three-dimensional mapping system,…
The purpose of the study is to compare these two drugs in view of how quickly and to what extent the drugs are absorbed and eliminated from the body (this is called pharmacokinetics) after injection under the skin of the abdomen.In addition, it will…